Non-small Cell Lung Cancer
Conditions
Sponsors
Novartis Pharma. K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed NSCLC stage IB-IIIA (per AJCC 8th edition), deemed suitable for primary resection by treating surgeon, except for N2 and T4 tumors. - Subject must be eligible for surgery and with a planned surgical resection in approximately 4-6 weeks (after the first dose of study treatment). - A mandatory newly obtained tissue biopsy from primary site is required for study enrollment. An archival biopsy is also acceptable if obtained up to 5 months before first day of study treatment and if the subject did not go through antineoplastic systemic therapies between biopsy collection date and beginning of study treatment. - Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.
Exclusion criteria
Exclusion criteria: - Subjects with unresectable or metastatic disease. - History of severe hypersensitivity reactions to monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction - Subjects who received prior systemic therapy (including chemotherapy, other anti-cancer therapies and any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) in the past 3 years before screening - Active autoimmune disease that has required systemic treatment in the past 2 years prior to randomization. Control of the disorder with replacement therapy is permitted - Subject with suspected or proven immunocompromised state or infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response (MPR) rate based on Central review This will assess the rate of MPR at the time of surgery in all participants randomized to canakinumab alone and in combination with pembrolizumab arms based on central review. | — |
Countries
Asia except Japan, Europe, Japan
Contacts
Public ContactTakamitsu Hirano
Novartis Pharma. K.K.
Outcome results
None listed